{ "id": "tamiflu", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Tamiflu", "generic": "奥司他韦", "aliases": [ "oseltamivir" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国当前公开标签档案（DailyMed SPL v45，2025-12-19 发布）", "dosageFormClass": "口服胶囊；口服混悬液用粉末（复溶后）（DailyMed 2025 标签所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1999（DailyMed 当前公开标签所列美国初始批准）", "archiveSponsorText": "Genentech / DailyMed 公开标签与 FDA 历史监管档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-tamiflu-capsule-75mg-10-capsule-blister-ndc-0004-0800-85", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v45，2025-12-19 发布；仅为所引公开标签展示面，不代表供应", "en": "DailyMed SPL v45, published 19 Dec 2025; cited public label panel only, not availability" }, "dosageForm": { "zh": "TAMIFLU 奥司他韦磷酸盐口服胶囊", "en": "TAMIFLU oseltamivir phosphate oral capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0004-0800-85", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒 75 mg；10 粒泡罩卡纸盒", "en": "75 mg per capsule; 10-capsule blister-card carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tamiflu-04.jpg&setid=ee3c9555-60f2-4f82-a760-11983c86e97b&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奥司他韦", "en": "oseltamivir" }, "value": 75, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、疗程或与混悬液自行换算", "en": "labelled amount per capsule; not an individual's capsule count, course or self-conversion to suspension" } } ], "concentration": null, "container": { "typeCode": "unit_dose_blister", "typeLabel": { "zh": "泡罩卡纸盒", "en": "blister-card carton" }, "fill": null, "countPerPackage": 10, "countUnit": { "zh": "粒/盒", "en": "capsules per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 10, "unit": { "zh": "粒/盒", "en": "capsules per carton" } }, "physicalClues": { "color": { "zh": "灰色与浅黄色", "en": "grey and light yellow" }, "shape": { "zh": "硬明胶胶囊", "en": "hard gelatin capsule" }, "imprint": "ROCHE / 75 mg", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_5e49cf1bebe9cd67", "label": "DailyMed（NLM）：TAMIFLU 当前公开标签（Genentech；SPL v45，2025-12-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee3c9555-60f2-4f82-a760-11983c86e97b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-tamiflu-oral-suspension-6mg-per-ml-60ml-bottle-ndc-0004-0822-05", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v45，2025-12-19 发布；仅为所引公开标签展示面，不代表供应", "en": "DailyMed SPL v45, published 19 Dec 2025; cited public label panel only, not availability" }, "dosageForm": { "zh": "TAMIFLU 奥司他韦磷酸盐口服混悬液用粉末（复溶后）", "en": "TAMIFLU oseltamivir phosphate powder for oral suspension (after reconstitution)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0004-0822-05", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "concentration", "primaryDisplay": { "zh": "6 mg/mL；60 mL 复溶后可用口服混悬液瓶装", "en": "6 mg/mL; 60 mL usable reconstituted oral-suspension bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tamiflu-05.jpg&setid=ee3c9555-60f2-4f82-a760-11983c86e97b&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奥司他韦", "en": "oseltamivir" }, "value": 6, "unit": "mg", "basisCode": "concentration", "basisLabel": { "zh": "标签浓度；不是个人毫升数、配制步骤或与胶囊自行换算", "en": "labelled concentration; not an individual's millilitres, reconstitution steps or self-conversion to capsules" } } ], "concentration": { "basisCode": "mass_per_volume", "notation": "6 mg/mL", "numerator": { "value": 6, "unit": "mg" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "6 mg/mL（标签浓度；不是个人毫升数）", "en": "6 mg/mL (labelled concentration; not an individual's millilitres)" } }, "container": { "typeCode": "reconstitution_bottle", "typeLabel": { "zh": "复溶后口服混悬液瓶装", "en": "reconstituted oral-suspension bottle" }, "fill": { "value": 60, "unit": "mL" }, "countPerPackage": 1, "countUnit": { "zh": "瓶/盒", "en": "bottle per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "瓶/盒", "en": "bottle per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_5e49cf1bebe9cd67", "label": "DailyMed（NLM）：TAMIFLU 当前公开标签（Genentech；SPL v45，2025-12-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee3c9555-60f2-4f82-a760-11983c86e97b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-tamiflu-capsule-75mg-10-capsule-blister-ndc-0004-0800-85", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tamiflu-04.jpg&setid=ee3c9555-60f2-4f82-a760-11983c86e97b&type=img", "alt": "TAMIFLU 75 mg 奥司他韦胶囊在美国 DailyMed 公开标签中的 Genentech 10 粒装包装主展示图", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v45（2025-12-19 发布）", "presentation": "TAMIFLU 75 mg、10 粒胶囊装包装主展示图（DailyMed 公开标签所列；Genentech 标签图）。", "notice": "此为美国 DailyMed 公开标签中明确对应 TAMIFLU 75 mg、10 粒胶囊装的 Genentech 包装标签图，只帮助核对品牌、通用名、标示强度、胶囊和来源；不用于鉴定真伪，也不证明 30 mg/45 mg、口服混悬剂、其他包装、其他市场标签、当前包装、原研身份、目标市场批准或可售资格。", "source": { "id": "src_5e49cf1bebe9cd67", "label": "DailyMed（NLM）：TAMIFLU 当前公开标签（Genentech；SPL v45，2025-12-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee3c9555-60f2-4f82-a760-11983c86e97b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "TAMIFLU 说明书放大阅读：胶囊与口服混悬剂不能只按“都是奥司他韦”互换", "en": "TAMIFLU label reading: capsules and oral suspension are not interchangeable simply because both contain oseltamivir" }, "summary": { "zh": "本模块以 DailyMed 2025 当前美国公开标签为阅读入口，帮助核对 TAMIFLU、奥司他韦、胶囊或复溶后口服混悬液、每个单位的标示强度/浓度和目标市场；它不把包装数字换算为个人的服用数量、补服方案或处方。", "en": "This module uses the current 2025 U.S. DailyMed public label as a reading entry point. It helps check TAMIFLU, oseltamivir, capsule or reconstituted oral suspension, labelled strength/concentration and target market; it does not convert package numbers into an individual's amount, make-up plan or prescription." }, "checks": [ { "zh": "先把商品名、通用名、剂型和规格放在一起看。胶囊上的 mg 与混悬液的浓度、量具和体积不是同一种信息；不能因都写奥司他韦，便自行把“几粒”改成“几毫升”或反向换算。", "en": "Read brand, generic name, dosage form and strength together. Milligrams on a capsule and the concentration, measuring device and volume of a suspension are not the same information; sharing oseltamivir does not permit self-conversion from “capsules” to “millilitres” or back." }, { "zh": "流感样症状、年龄、体重、肾功能、起病时间、实际产品及当地标签都会影响专业人员怎样核对处方。网页不判断是否应开始、何时开始、是否补用或能否把家中余药给另一位家人。", "en": "Flu-like symptoms, age, weight, kidney function, time since symptoms began, the actual product and local label all affect how professionals review a prescription. This page does not decide whether or when to start, make up a use, or give leftover medicine to another family member." }, { "zh": "TAMIFLU 是抗流感病毒产品的身份信息，不表示对普通感冒、细菌感染或所有发热咳嗽都能自行替代抗生素或其他药。合并的退烧、止咳、感冒、慢病和补充剂应作为完整药单交由药师或开方团队核对。", "en": "TAMIFLU identifies an influenza antiviral product; it does not establish that a common cold, bacterial infection or every fever and cough can be self-managed by replacing an antibiotic or another medicine. Fever, cough/cold, chronic-care and supplement products should be reviewed together as a complete medicine list." }, { "zh": "出现呼吸困难、意识改变、无法进食饮水、持续恶化，或对剂型、量具和标签不确定时，应及时使用当地医疗与专业支持渠道；本页不替代急性病情评估。", "en": "With breathing difficulty, altered awareness, inability to eat or drink, continued deterioration, or uncertainty about dosage form, measuring device or label, use timely local medical and professional support; this page does not replace assessment of acute illness." } ], "source": { "id": "src_5e49cf1bebe9cd67", "label": "DailyMed（NLM）：TAMIFLU 当前公开标签（Genentech；SPL v45，2025-12-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee3c9555-60f2-4f82-a760-11983c86e97b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "奥司他韦怎样起作用：它抑制流感病毒的神经氨酸酶", "en": "How oseltamivir works: it inhibits influenza-virus neuraminidase" }, "summary": { "zh": "FDA 标签将奥司他韦描述为流感病毒神经氨酸酶抑制剂；这一机制帮助解释它为什么属于抗流感病毒产品。它不诊断流感、不判断何时开始、不给出个人剂量，也不把它变成针对细菌感染或普通感冒的替代品。", "en": "The FDA label describes oseltamivir as an influenza-virus neuraminidase inhibitor; this helps explain why it is an influenza antiviral product. It does not diagnose influenza, decide when to start, give an individual dose, or turn it into a substitute for bacterial infection or the common cold." }, "checks": [ { "zh": "“抑制神经氨酸酶”是解释病毒传播相关路径的机制词，不是任何发热、咳嗽或接触史下自行用药的指令。是否适用及如何使用仍需依据准确产品的现行标签、病情评估和处方团队。", "en": "“Inhibiting neuraminidase” describes a pathway related to viral spread; it is not an instruction for self-use with every fever, cough or exposure history. Suitability and use still require the current label for the exact product, clinical assessment and the prescribing team." }, { "zh": "该机制不使 TAMIFLU 与抗生素、其他抗病毒药、退烧药或感冒复方药可自行叠加、替换或按名称判断安全。多药情境应让药师或医生核对完整药单与实际产品。", "en": "This mechanism does not make TAMIFLU self-combinable, substitutable or automatically safe with antibiotics, other antivirals, fever medicines or multi-ingredient cold products. In a multiple-medicine situation, have a pharmacist or clinician review the complete list and actual products." }, { "zh": "胶囊与口服混悬剂的区别属于产品身份和制剂信息，不会因机制相同就能相互换算。任何关于毫升、量具、胶囊数量、漏用或余药的疑问都应回到产品标签与专业人员。", "en": "The difference between a capsule and oral suspension is product-identity and formulation information; a shared mechanism does not make them convertible. Questions about millilitres, measuring devices, capsule count, missed use or leftover medicine must return to the product label and professionals." } ], "source": { "id": "src_5e49cf1bebe9cd67", "label": "DailyMed（NLM）：TAMIFLU 当前公开标签（Genentech；临床药理；SPL v45，2025-12-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee3c9555-60f2-4f82-a760-11983c86e97b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Tamiflu", "generic": "奥司他韦", "dosageFormClass": "口服胶囊；口服混悬液用粉末（复溶后）（DailyMed 2025 标签所列）" }, "labelSource": { "id": "src_5e49cf1bebe9cd67", "label": "DailyMed（NLM）：TAMIFLU 当前公开标签（Genentech；SPL v45，2025-12-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee3c9555-60f2-4f82-a760-11983c86e97b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_5e49cf1bebe9cd67", "label": "DailyMed（NLM）：TAMIFLU 当前公开标签（Genentech；SPL v45，2025-12-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee3c9555-60f2-4f82-a760-11983c86e97b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_cfab00b9ba7c705d", "label": "FDA：TAMIFLU 2019-08 美国历史标签（NDA 021087 / 021246）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021087s071%2C021246s054lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "Genentech 的 DailyMed TAMIFLU（oseltamivir phosphate）当前美国公开标签列示口服胶囊与口服混悬液用粉末（复溶后），并标示美国初始批准年份为 1999。本页分别记录一个 75 mg 胶囊泡罩卡面板与一个 6 mg/mL、60 mL 复溶后口服混悬液瓶装面板；不据此推定其他规格、其他市场批准、原研关系、供应或可售资格。", "history": "胶囊的 mg 与复溶后混悬液的 mg/mL 是不同的标签身份字段。共同品牌、共同成分或相近数字均不产生自行换算、配制、换药、补用或购买结论。", "sourceDocuments": [ { "id": "src_5e49cf1bebe9cd67", "label": "DailyMed（NLM）：TAMIFLU 当前公开标签（Genentech；SPL v45，2025-12-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee3c9555-60f2-4f82-a760-11983c86e97b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_cfab00b9ba7c705d", "label": "FDA：TAMIFLU 2019-08 美国历史标签（NDA 021087 / 021246）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021087s071%2C021246s054lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 021087 / 021246", "approvalTimeline": [ { "date": "1999", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1999。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1999. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_5e49cf1bebe9cd67", "label": "DailyMed: TAMIFLU current public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee3c9555-60f2-4f82-a760-11983c86e97b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "DailyMed SPL v45, 2025-12-19", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 DailyMed SPL v45, 2025-12-19 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the DailyMed SPL v45, 2025-12-19 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_5e49cf1bebe9cd67", "label": "DailyMed: TAMIFLU current public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee3c9555-60f2-4f82-a760-11983c86e97b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/tamiflu/", "en": "https://origindrug.com/en/drugs/tamiflu/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }